Att 7_Human Subject

REQUEST FOR DETERMINATION OF RESEARCH STATUS
To be completed by the staff member with lead responsibility for the project and approved by branch chief (if applicable) and Division
ADS. A separate PGO funding memo is required if project is research and involves human subjects regardless of the CDC staff role.
Instructions:

(1) Use this form to declare: (a) the research status of any project, (b) role or roles of CDC staff
(2) A short summary should be attached offering specific details about the project and the role of staff.
(3) Be sure to complete all applicable items, obtain appropriate signatures and submit this form for approval.

Tracking Number:

TBD/TBD

(Use PGO number if cooperative agreement, grant, etc.)
Date submitted:

02/02/2017

Title of Project:

Assessment and Monitoring of Breastfeeding-related Maternity Care Practices in the U.S. (Maternity
Practices in Infant Nutrition and Care ±and 2022 mPINC survey)

Dates for project period:

Dates for funding (if applicable):

Beginning:

09/25/2017

Beginning:

Ending:

12/31/2022

Ending:

Project is (choose one):
NOTE: Revision, as used below, refers to any substantive change made to the project including scope of project, funding restrictions,
personnel, role of CDC staff member, determination of research status, etc.
[X]

New

[]

Revision

[]

Continuation, without revision(s)

[]

Continuation, with revision(s)

Lead staff member:

Contact information:

Name:

Daurice Grossniklaus

Division:

User ID:

DTG3

Telephone: 770-488-5249

Scientific Ethics number:

1.

Please indicate your role(s) in this project:

1761 Mailstop:

DNPAO

F77

[]

Project officer

[X]

Technical monitor

[]

Principal
investigator

[]

Investigator

[]

Consultant

[]

Other (please explain)

Are any or all of the activities within this project DESIGNED to contribute to generalizable knowledge (i.e., research)?
[]

[X]

YES

NO

If YES, list those activities which are research:

2.

Is this CDC project research or public health practice (check all that apply)?
[]

3.

Research

[X]

Public health practice

Check one:

Check all that apply:

[]

Human subjects involved

[]

Emergency Response

[X]

Surveillance

[]

Human subjects not involved

[]

Program evaluation

[]

Other (please explain)

If RESEARCH involving human subjects, has the project or research activities been reviewed by the CDC IRB for human
subjects protection?
a. [ ]

NO, New project, not yet reviewed

d. [ ]

b. [ ] NO, Existing project, not ready to submit

YES, Reviewed and approved by CDC
If YES, please list protocol number and

c. [ ] NO, Submitted for approval

expiration date
e. [ ]

NO, RESEARCH, no CDC investigators (CDC IRB not
required)

f. [ ]

N/A (Not Applicable)

If RESEARCH, list any other CDC staff involved in this project, please include the name, role, and scientific ethics number

Form 684R_NR (revised January 2003)
ID:

26896

1

Tracking NO. TBD/TBD
Name

Role (project officer, investigator,
consultant, etc.)

Scientific ethics
number Prin

Daurice Grossniklaus

1761

IF YOU THINK THE RESEARCH PROJECT MIGHT QUALIFY AS EXEMPT RESEARCH (as identified in 45CFR46.101),
PLEASE ANSWER questions 4-6, OTHERWISE SKIP TO question 7.
4.

5.

Does the proposed research involve prisoners?
[ ]

YES

[ ]

NO

If YES, this research cannot be exempted and must be reviewed by an IRB (skip to question 7).

Does the proposed research involve fetuses, pregnant women, or human in vitro fertilization as targets (such that Subpart B
would apply)?
[ ]

YES

[ ]

NO

If YES, this research cannot be exempted and must be reviewed by an IRB (skip to
question 7).

Educational Research
6.1

Is this research conducted in established or commonly accepted educational settings, AND does the research involve
normal educational practices (e.g., research on regular and special education strategies or research on the
effectiveness of, or comparison among instrucational techniques, curricula or classroom management methods)?
[ ]

YES

[ ]

NO

Research Involving Surveys, Interview Procedures (including Focus groups), Observation of Public Behavior, or Educational
Tests
6.2

Will this research use educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview
procedures or observation of public behavior?
[ ]

YES

[ ]

NO

If NO skip 6.3

Will children (<18 years of age) be research subjects?
[ ]

YES

[ ]

NO

6.2.1

Is the information obtained recorded in such a manner that human subjects can be identified directly or
indirectly through identifiers (such as a code) linked to the subjects;
[ ]

6.2.2

YES

[ ]

NO

Will any disclosure of the human subjects' responses outside of the research setting have the potential to
place the subjects at risk of criminal or civil liability, or be damaging to the subjects' financial standing,
employability or reputation? (Examples here may include: the collection of sensitive data regarding the
subjects' (or relatives' or associates') possible substance abuse, sexuality, criminal history or intent, medical
or psychological condition, financial status, or similarly compromising information).
[ ]

6.3

If YES, this research cannot be exempted and must be reviewed by an IRB (skip to item 7)

YES

[ ]

NO

Will this research use educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview
procedures, or observation of public behavior but the research is not exempt under paragraph 6.2 of this section:
[ ]

YES

6.3.1

Will this research involve human subjects that are elected or appointed public officials or candidates for
public office?
[ ]

6.3.2

[ ]

YES

NO

[ ]

If NO skip to 6.4

NO

Does federal statute(s) require(s) without exception that confidentiality of the personally identifiable
information will be maintained throughout the research and thereafter? (Note: CDC can use this exemption
criterion only in the case where a 308(d) Assurance of Confidentiality has been obtained to cover the
research).
[ ]

YES

[ ]

NO

Existing Data Which Is Publicly Available or Unidentifiable
6.4

Does this research involve only the collection or study of existing* data, documents, records, pathological or
diagnostic specimens? (* 'existing' means existing before the study begins)?
[ ]

YES

6.4.1

Is this material or information publicly available?
[ ]

[ ]
YES

Form 684R_NR (revised January 2003)
ID:

26896

NO
[ ]

If NO skip to 7
NO

2

Tracking NO. TBD/TBD
6.4.2

Is this material or information recorded in such a manner by the investigator that the subjects cannot be
identified directly or indirectly through identifiers linked to the subjects?
(Note: If a link is created by an investigator even temporarily, for research purposes, this criterion is not met.
If a temporary link is created by clinical staff who already have access to the data, this criterion is met).

7.

[ ]

YES

(there are no identifying information and no unique identifiers or codes)YES

[ ]

NO

(there are identifiers (including codes))

Please prepare and attach a short summary paragraph (<1 page);
if this is new:
a.

Be sure to include the purpose of the project, specific details about the project and the role of the CDC staff member
(s) in the project. In explaining one's role as a consultant be particularly careful to identify involvement in things
like: study design decisions, oversight of protocol development, participation in review of data collection procedures,
and particpation in data analysis and/or manuscript preparation, as well as whether there will be access to
identifiable or personal data.

b.

Explain your project status selection (research--non-exempt, exempt, no CDC investigator or not involving human
subjects; public health practice). If you selected research not involving human subjects be sure to indicate if the data
includes any personal information (e.g., name, SSN), linkable study identification numbers or codes, or geographical
information.
7a. The purpose of this project is to track the maternity care practices that support breastfeeding in hospitals. Since 2007, CDC
has administered the national survey of maternity care practices related to breastfeeding, known as the Maternity Practices in
Infant Nutrition and Care (mPINC) Survey on a biennial basis in order to monitor and examine changes in these practices over
time. The mPINC survey uses a census design and is administered to every facility in the US that routinely provides maternity
care services. A staff person completes the mPINC survey on behalf of his or her institution in their capacity as the person
most knowledgeable about the relevant practices. The first survey in 2007 established a measure of the prevalence of specific
breastfeeding-related maternity care practices at maternity care facilities across the United States and Territories at that point
in time and the extent to which these practices vary by state. In addition to providing prevalence measures at subsequent
points in time, biennial analyses of data from the 2009 - 2015 surveys provide important information about changes and trends
in practices since the initial baseline assessment. The current RFTP is intended to continue work similar to that of the previous
surveys. The 2020 mPINC survey is intended to be completed within the scope of the Information Collection Review (ICR)
currently being submitted to cover the mPINC 2018 administration or under a new ICR to be submitted prior to the 2020
mPINC administration. Access to data, processes, surveys, and reports on previous mPINC surveys is available at
www.cdc.gov/mpinc and http://www.reginfo.gov/ (search ³OMB Control Number: 0920-0743´for complete records of 20072016 OMB activity related to this project). CDC staff monitor the contract and conduct analyses on data from the survey.
Analyzed data will be linked to hospital identification number, hospital name and hospital address in order for the Contractor
conducting the survey to disseminate hard copy and/or electronic versions of hospital-specific benchmark reports. The web
survey will include an item for the survey recipient's permission to retain their title, hospital affiliation, and hospital email
address so that an electronic copy of the hospital-specific benchmark report can be emailed to the survey recipient in lieu of a
paper copy.
7b. This project is public health practice. The data collected are part of an ongoing surveillance system tracking hospital
practices that support breastfeeding. Although the data has the potential to be used for research, the primary purpose of the
data collection is for surveillance and monitoring. No human subject research will be conducted under this request. If human
subject research is conducted a new Research Determination will be submitted.

8.

Please list the primary project site and all collaborating site(s).
Explanation of project components:

9.

If project involves research that is funded extramurally, list amount of award that should be restricted pending IRB
approval and describe which project components will be affected, if known:

Approvals (signature and position title)
Latetia Moore Freeman - Deputy Associate
Director for Sc

Date
02/03/2017

Research Determination / Remarks
[X]
[ ]
[ ]
[ ]
[ ]

Public health practice
Research not involving human subjects
Research involving human subjects, no CDC investigators
Research involving human subjects, CDC investigators, exempt
Research involving human subjects, CDC investigators, not exempt

(check if applicable)
[ ]
Local IRB
[ ]
CDC Exemption
[ ]
CDC IRB
staff member completing this form

Form 684R_NR (revised January 2003)
ID:

26896

Comments:
LV Moore reviewed and approves
3

Deborah Galuska - ASSOCIATE
DIRECTOR SCIENCE

02/03/2017

[X]
[ ]
[ ]
[ ]
[ ]

Public health practice
Research not involving human subjects
Research involving human subjects, no CDC investigators
Research involving human subjects, CDC investigators, exempt
Research involving human subjects, CDC investigators, not exempt

(check if applicable)
[ ]
Local IRB
[ ]
CDC Exemption
[ ]
CDC IRB
Team Lead

Comments:

Deborah Galuska - ASSOCIATE
DIRECTOR SCIENCE

02/03/2017

[X]
[ ]
[ ]
[ ]
[ ]

Public health practice
Research not involving human subjects
Research involving human subjects, no CDC investigators
Research involving human subjects, CDC investigators, exempt
Research involving human subjects, CDC investigators, not exempt

(check if applicable)
[ ]
Local IRB
[ ]
CDC Exemption
[ ]
CDC IRB
Division ADS

Comments:

Joan Redmond Leonard - PUBLIC
HEALTH ANALYST

02/21/2017

[X]
[ ]
[ ]
[ ]
[ ]

Public health practice
Research not involving human subjects
Research involving human subjects, no CDC investigators
Research involving human subjects, CDC investigators, exempt
Research involving human subjects, CDC investigators, not exempt

(check if applicable)
[ ]
Local IRB
[ ]
CDC Exemption
[ ]
CDC IRB
CUC ADS, Deputy ADS, or Human
Subjects Contact

Form 684R_NR (revised January 2003)
ID:

26896

Comments:

4